STANDARD SUMMARY PROJECT FICHE

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STANDARD SUMMARY PROJECT FICHE

  1. 1. STANDARD SUMMARY PROJECT FICHE 1. Basic Information 1.1 Publication and Twinning Number: BG 2006/018-343.06.01, BG 06 IB SO 01 1.2 Title: Strengthening of administrative structures for radiation protection and safety use of ionizing radiation in diagnostics and therapy 1.3 Location: Bulgaria 2. Objectives 2.1 Overall Objective(s): Strengthening of the administrative and institutional health care structures in Bulgaria in regard to the radiation protection, reduction of the radiation exposure of the population at medical use of ionizing radiation as required in the Directive 96/29 EURATOM and the Medical Exposures Directive 97/43/EUROATOM, raising the level of the medical services and by this approaching a better quality of life. 2.2 Project purpose: Increasing the safety use of ionizing radiation for medical purposes and effectiveness of early cancer diagnostics and treatment, applying comprehensive QA policy in diagnostic radiology, nuclear medicine and radiotherapy and innovation and enhancing the activity of the Secondary Standard Dosimetry Laboratory in accordance to the EC requirements. 2.3 Contribution to National Development Plan /Cooperation agreement N/A 3. Description 3.1 Background and justification: Provisions for organisation of the state system for radiation protection in Bulgaria were set in the Order No 117 of 7th April 1964 of the Council of Ministers. The Ministry of Health was charged with the preparation of adequate regulations on the use of ionising radiation sources and the state supervision and control of such activities. In the seventies a number of legislative documents were issued regarding the different aspects of the radiation protection and safety use of radioactive materials. At this time the majority of sources of ionising radiation were x-ray generators and sealed sources for application in medicine and in industry. The licensed work sites for medical use of ionising radiation in Bulgaria are situated in big hospitals and ambulances with a lot of radiation sources. Due to the new economical changes the private medical practices using ionising sources increase continuously. Currently the equipment used in the hospitals includes: • Diagnostic Radiology: more than 2000 machines and of them 120 Mammography units, 480 Dental, and 120 CT Scanners. • Nuclear Medicine: 30 Linear Scanners, 10 planar Gamma Cameras and 8 SPECT Gamma Cameras • Radiotherapy: Multi-mode accselerators – 2 LINACs; 11 Teletherapy (Cobalt 60) Units; 15 orthovoltage and 14 superficial X-ray therapy machines; Brachytherapy with 1 HDR remote
  2. 2. afterloading unit (192 Ir) and 9 centers with manual afterloading (137 Cs for gynaecological applicators and 192 Ir wires for interstitial applications). The Ministry of Health has prepared a national strategy for modernization of radiotherapy by supply of linear accelerators, high dose rate brachytherapy equipment, computed tomography (CT) scanners and X-ray simulators. At present, the matters of safety at work in nuclear and radiation facilities, and especially the problems concerning radiation and individual dose and health monitoring of occupationally exposed workers are regulated in accordance with the European Directives in the following acts, adopted by the Parliament: o Act of the Safe Use of Nuclear Energy (Promulgated in the State Gazette No. 63 of June 28, 2002), o Act on Health (Promulgated in the State Gazette No. 70 of August 10, 2004), o Act on Safe Conditions of Labour. The standards for the protection of individuals from the harmful effects of ionizing radiation are stated by the Regulation for Basic Norms for Radiation Protection, promulgated in the State Gazette No.73 of August 20, 2004 stated by the Governmental Decree No. 190 from 30 July 2004, which is in accordance with the Council Directive 96/29/EURATOM (OJ L 159, 29. 6. 96). The authorities having competence for development and implementation of legislation on radiation protection in Republic of Bulgaria are the Nuclear Regulatory Agency (NRA), the National Centre of Radiobiology and Radiation Protection (NCRRP) under the Ministry of Health and the Ministry of Environment and Water (MEW). The Council Directive 97/43/EURATOM for health protection of individuals against the dangers of ionizing radiation in relation to medical exposures is transposed into Bulgarian legislation by a new Ordinance of the Ministry of Health No30 from 31 October 2005 for Protection of Individuals at Medical Exposure, promulgated in State Gazette № 91 of November 15, 2005. The Ministry of Health is charged with the organization, coordination and control over all activities directed towards protection of human health and assurance of healthy working conditions for the population. Concerning the problem of radiation protection and safety at the medical use of ionizing radiation, several institutions within the Ministry of Health such as the National Centre of Radiobiology and Radiation Protection (NCRRP) and five Radiation Protection Inspectorates (in Plovdiv, Varna, Burgas, Vratsa, Rousse) carry out preventive and routine control in the country. The requirements of the Ordinance for Protection of Individuals at Medical Exposure based on the Council Directive 97/43 EURATOM has to meet a number of new activities and create new structures in order to be implemented until the end of 2007. This Ordinance stated new demands to radiological practices and set higher requirements to radiological equipment, which have not been previously included in the Bulgarian legislation. Introduction of these new requirements needs building up of new administrative structures, adequate training and qualification of professionals, which would be supported by some of the activities proposed in the present project. The building of the administrative capacity to fulfil these objectives has started within the scope of the previous PHARE Project BG/2000/IB/EN 01-05 “Radiation Protection and Safety at the Medical Use of Ionizing Radiation”. As a result of this project Quality Assurance programmes in medical use of ionizing radiation were elaborated. These Programmes have to be implemented into clinical practice in recent years. As stated in the Ordinance for Protection of Individuals at Medical Exposure within five years after its publication, the radiological practice 2
  3. 3. in the country should cover all EU requirements. The process of practical realisation of Quality control and Radiation protection will be enforced by the supply of necessary highly specialised equipment within the investment part of the present project. One of the crucial points to fulfil the EU requirements remains guaranteeing the accuracy of measuring devises for clinical dosimetry and for quality control in radiotherapy, nuclear medicine, diagnostic radiology and radiation protection as well as the traceability of the measurements to the National and International standards. These responsibilities are assigned to the National Secondary Standard Dosimetry Laboratory (SSDL) - unique for the country. This laboratory (SSDL) was established in late 70-thies to provide accuracy of the radiation treatment procedures by acceptance testing and calibration of radiotherapy units and to ensure metrologically the National system for individual dose monitoring in medicine as well in all other licensed radiation facilities incl. Nuclear Power Plant Kosloduy. The system for individual dose monitoring includes approximately 14 000 persons. The radiation protection monitors are also under the SSDL periodical checks including approximately 800 dosemeters per year. Since 1980 the SSDL regularly takes part in IAEA/WHO TLD Postal Dose Quality Audit for high energy photons from cobalt-60 and Cs-protection level. The implementation of the requirements of EC Directive 97/43 EURATOM put new demands concerning Quality control of radiological equipment and patient dosimetry, new generation of control and measuring instruments and further introduction of dosimetric and calibration methods. All these imply further development of the SSDL. Presently the SSDL works with more than 30 years old equipment and that is one of the reasons not to be accredited in the last years. This fact constrains the ensuring accuracy of radiotherapy procedures and of the radiation protection measuring equipment. In this regard the SSDL urgently needs innovation by supply of modern calibration equipment and know-how transfer for updating the calibration methodology. This will be accomplished within the investment part of this project. 3.2 Linked activities: The Ministry of Health has been responsible for the implementation of the PHARE Project BG/2000/IB/EN 01-05 “Radiation Protection and Safety at the Medical Use of Ionizing Radiation”. Its wider objective was to assist in transposing and implementing the requirements of the Basic Safety Standards Council Directive 96/29/EURATOM and Council Directive 97/43/EURATOM for health protection of individuals against the dangers of ionizing radiation in relation to medical exposures by improving the institutional and administrative framework. During the project a draft of Ordinance for patient protection from medical exposure has been prepared; a large scale national patient dose survey in Diagnostic Radiology has been conducted and as a result national reference patient dose levels were elaborated. A national data base has been prepared for monitoring the patient dose in the country. Quality control programmes were elaborated for all three areas of medical use of ionizing radiation and a pilot project for their practical implementation. New programmes for education and training in radiation protection have been designed for different groups of specialists involved into the medical exposure. A public awareness campaign has been conducted for the risk and benefit from the medical use of radiation. As a result of the project a big step has been done toward the enhancement of the quality of diagnosis and treatment and radiation protection at medical use of ionizing radiation in Bulgaria. The present project submitted for Phare 2006 AP Environment is proposed as a direct continuation of the above mentioned project BG/2000/IB/EN 01-05 and it envisages the full implementation of the Council Directive 97/43 EURATOM into radiological practice mainly 3
  4. 4. focused on QA and Radiation Protection in Radiotherapy and enhancing the national system for metrological assurance of radiological practices. 3.3 Results: 3.3.1 Building of modern and effectively operating National Secondary Standard Dosimetry Laboratory (SSDL) with the capacity to perform the following activities for: • Calibration and metrological control of radiometers, dosemeters and quality control measuring devices for Radiotherapy, Nuclear Medicine, Diagnostic Radiology and Radiation Protection based on up to date methodology; • Inter-comparison between radiotherapy treatment systems based on internationally approved advanced methods. • Technological and methodological preparation for certification of the SSDL in accordance with national requirements. 3.3.2 Developed system for quality audit in radiotherapy by: • Creation of QA programme for all modalities used in radiotherapy; • Pilot implementation of QA and QC procedures in a leading radiotherapy centre; • Definition of scenarios for most probable accidental exposures in radiotherapy with corresponding emergency protocols. 3.3.3 Optimised Radiation Protection of patients in Diagnostic Radiology and Nuclear Medicine by: • Updating the previously established Diagnostic Reference Levels (DRL) in Diagnostic Radiography and Nuclear Medicine; • Establishing new DRL for fluoroscopy guided procedures; • Performing of a National Survey of Computed Tomography (CT) practice and establishing DRL in CT; • Enlargement of national data base for patient dose monitoring including the number and frequency of X-ray examinations. • Improving the methodology for estimation of the population radiation exposure due to medical procedures. 3.3.4 – Supply of necessary equipment for calibration, radiation protection measurements and quality control. 3.3.5. Techical Specifiations elaborated 3.4 Activities: 3.4.1.1. Preparatory activities for SSDL modernization with long term training of three Bulgarian specialists in a partner SSDL for know-how transfer. 3.4.1.2. Definition and preparation of Technical Specifications 3.4.1.3. Supply and distribution of the necessary measurement and control equipment 3.4.1.4. Updating the methodology for calibration and metrological control of radiometers, dosimeters and quality control measuring devices used in Radiotherapy, Nuclear Medicine, Diagnostic Radiology and Radiation Protection on the base of the European and International standards. 4
  5. 5. 3.4.1.5. Improvement of the methods for traceability of measurements and inter laboratory comparisons between radiotherapy treatment systems 3.4.1.6. Preparation and application for certification of SSDL in accordance with national institutional requirements. 3.4.2.1 Creation of a national protocol for Quality Control in radiotherapy 3.4.2.2. Development of QA programmes in radiotherapy 3.4.2.3. Set up of a national auditing group for QA in radiotherapy as to EC-standards 3.4.2.4. Pilot implementation of the QA and QC procedures in a leading radiotherapy centre 3.4.2.5. Drafting scenarios for most probable accidental exposures in radiotherapy and emergency action protocols. 3.4.3.1 Enlargement of the national survey as to the utilized methodology for measurement and evaluation of patient doses in conventional radiography 3.4.3.2. Review of the national survey on the applied activities and standards in NM 3.4.3.3. Setting a national survey of CT practice – defining methodology, performing measurements, dose assessment for the standard CT examinations 3.4.3.4. Updating the established DRL in Diagnostic Radiography and NM and determination of DRL in fluoroscopy guided procedures and CT. 3.4.3.5. Enlargement of the existing national data base for patient dose monitoring by elaboration of special sheet for collection of number and frequency of X-ray examinations. 3.4.3.6.Improving the methodology for estimation of the radiation burden of the population due to medical exposure 3.4.4. Elaboration and review of the Technical Specifications for the equipment 3.5. Profile of the RTA The Resident Twinning Adviser (RTA) should have at least 15 years experience in implementing the EU legislation in radiation protection at medical use of ionising radiation and management of radiation protection practice and to be on 12 months secondment duration of the project. 4. Institutional Framework The National Centre of Radiobiology and Radiation Protection is responsible for the organization and methodology, research, prevention, control, and diagnostics and treatment activities in the field of radiation protection of the population. The NCRRP has four departments: Radiation Protection, Radiation Control, Radiobiology, and Radiation Medicine. As a result of the former Project a new Laboratory at the NCRRP for Radiation Protection in Medicine has been established. Recently the Secondary Standard Dosimetry Laboratory has been included in the administrative structure of NCRRP. The five Radiation Protection Inspectorates in Plovdiv, Bourgas, Varna, Russe and Vratsa are regionally structured and work under the methodological guidance of the NCRRP. Within the Ministry of Health they are responsible for the performing of radiation control in health care facilities. The SSDL and the Laboratory for Radiation Protection in Medicine at the NCRRP as well as Oncological Centres in Sofia, Stara Zagora, Plovdiv, Shumen, Russe, Veliko Tarnovo, Vratsa, Varna, Gabrovo, Pleven and the Medical University Hospitals in Sofia, Plovdiv, Varna, Pleven are the target objects of the present project. The project is to be implemented under the direct control and supervision of a Steering Committee. The Committee will comprise of members from the Ministry of Health, National 5
  6. 6. Centre of Radiobiology and Radiation Protection, MoEW, CFCU, the EC Delegation in Sofia and from other institutions. With the aim to prepare, co-ordinate the necessary activities and consequently implement the elaborated documents and decisions in practice Working groups will be established. The National consultant of Radiotheraphy and different kinds of experts (practitioners, scientists, etc.) from the diverse institutions concerned will support the implementation of the twinning project and the work of respective Working groups, with relevant information and tools and coordination of activities when implying methods and procedures. The experts will closely collaborate with the twinning partner. Project Leader: Ivanka Rupova, Deputy Director of the NCRRP 132 Kliment Ohridsky blvd. 1756 Sofia Tel: +3592 9623947 Fax: +3592 621059 e-mail: v.rupova@ncrrp.org 5. Detailed Budget Phare Support €M Investment Support (I) Institution Building (IB) Total Phare (=I+IB) National Cofinancing * IFI* TOTAL Contract 1 Twinning covenant 0.700 0.700  0.700 Total 0.700 0.700 () Up to 10% of the Twinning project will be covered from the national budget through the National Fund Directorate at the Ministry of Finance. 6. Implementation Arrangements 6.1 Implementing Agency The CFCU will be the Implementing Agency responsible for tendering, contracting and accounting with assisting in good project design and implementation and Phare procurement and payment rules. The CFCU (Ministry of Finance) is in charge of the contracting and financial management of the project. Mrs. Gergana Beremska from the State Treasure, Ministry of finance will act as PAO of the project. Her contact details are: Mrs. Gergana Beremska State Treasure, Ministry of finance 102, “Rakowski” St. 6
  7. 7. 1040 Sofia Tel.: +359 2 9859 24 90 Fax: +359 2 980 68 63 g.beremska@minfin.bg 6.2 Twinning The Ministry of Health will be the body responsible for the day to day management of the project, for technical preparation and control. MoH contact point: Mihail Abrashev Management of Projects and Programmes Directorate Address: Ministry of Health 39, Alexander Stamboliyski Blvd 1000 Sofia, Bulgaria Tel: + 359 2 9301203 Fax: + 359 2 9872521 e-mail: mabrashev@mh.government.bg The twinning partner should assure to the project long- and short-term senior experts, working continuously on site. The twinning partner should represent a relevant administrative structure of a Member-State, with experience in implementation of EU Environmental Acquis. The twinning partner should provide a team of experts having at least 15 years of experience, knowledge and skills in quality assurance, dosimetry and radiation protection in Radiotherapy, Nuclear Medicine and Diagnostic Radiology, operation of Secondary Standard Dosimetry Laboratory, practical experience and management in relevant fields. The twinning partner should provide exchange of expertise by visits of Bulgarian experts in a relevant institution in partner country. The twinning partner should be actively involved in the commentary on draft texts and assisst in organization and performance of practical trainings connected to the project activities. The twinning partner should support promotion of the project results at national and international events. Profile of the short and medium term experts Short and medium term experts should have at least 15 years experience in radiation physis and medical physics applied to Radiotherapy, Nuclear Medicine and Diagnostic Radiology, in particular: Expert 1 should have experience in management of secondary standard dosimetry laboratory, practical operation, dosimetry and calibrations at level of SSDL. Expert 2 should have experience in performing and supervising quality assurance programmes in radiotheraphy and in organisation of quality audit; Expert 3 should have experience in performing patient dose measurements for different modalities in Diagnostic Radiology and realisation of national patient dose survey with establishment of DRL, as well as in estimation of the population radiation exposure due to medical procedures. 7
  8. 8. As English will be the working language, all experts are required to be fluent in English. The responsible person for twinning arrangement at MoH is: Mihail Abrashev, MD Chief Expert Management of Projects and Programmes Directorate Ministry of Health 39, Alexander Stamboliyski Blvd 1000 Sofia, Bulgaria Tel: + 359 2 9301204 Fax: + 359 2 9872521 e-mail: mabrashev@mh.government.bg 6.3 Non-standard aspects The Common Twinning Manual will strictly be followed. 6.4 Contracts Contract 1- Twinning contract 0.700 MEUR 7. Implementation Schedule 7.1 Start of tendering/call for proposals – October 2006 7.2 Start of project activity – June 2007 7.3 Project Completion – June 2008 8. Equal Opportunity All participating Bulgarian institutions are equal opportunity employers. No discrimination of whatever nature will be applied. 9. Environment The supplies will be delivered into existing premises. No environmental impact is expected and the supply of equipment does not require any sort of environmental assessment. The specifications will take into account the respective standards and norms applicable for IT systems. 10. Rates of return The equipment will not generate incremental costs related to the current running of the laboratories. Staff and premises exist and are running. It will nevertheless generate additional income thanks to the increased quantity/type of samples per year. Non-tangible benefits will be related to increased human health protection. 11. Investment criteria 8
  9. 9. a. Catalytic effect: The Phare contribution will accelerate the implementation of the radiation protection and safety policy and of the relevant legal framework. b. Cofinancing: Up to ten percent of the project costs will be financed through National public funds c. Additionality: The Phare contribution shall not displace other financiers. d. Project readiness and Size: The Phare contribution shall not displace other financiers. e. Sustainability: Sustainability of project results is assured through the need and commitment by Bulgaria to implement its radiation protection and safety policy in diagnostics and therapy. No new institutions or laboratories will be created. Staff increase (or decrease) is not expected as a result of the project. All supported investment actions (supplies) are sustainable in the long term beyond the date of Accession. They will comply with the EU norm and standards (accredited), and will be coherent with the sector policies of the EU. Future maintenance and operation costs will be covered by the Bulgarian national budget. f. Compliance with state aids provisions: All investments will respect the state aid provisions of the Europe Agreement. g. Contribution to National Development Plan: Not applicable 12. Conditionality and sequencing Projects to be implemented through twinning require the full commitment and participation of the senior management of the beneficiary institutions. In addition to providing the twinning partner with adequate staff and other resources to operate effectively, the senior management will be whole-heartedly involved in the development and implementation of the policies and institutional change required delivering the project results. Commitment in this sense has already been taken. ANNEXES TO PROJECT FICHE 1. Logical framework matrix in standard format (compulsory) 2. Detailed implementation chart (optinal) 3. Contracting and disbursement schedule by quarter for full duration of programme (including disbursement period) (optional) 4. Reference to feasibility /pre-feasibility studies. For all investment projects, the executive summary of the economic and financial appraisals, and the environmental impact assessment should be attached (optional) 5. List of relevant Laws and Regulations (optional) 6. Reference to relevant Government Strategic plans and studies (may include Institution Development Plan, Business plans, Sector studies etc) (optional) 9
  10. 10. Annex 1 Logframe Programme name and number: PROJECT: Strengthening of administrative structures for radiation protection and safety use of ionizing radiation in diagnostics and therapy Contracting period expires: November 2008 End of execution of contracts expires: November 2009 Total budget: : 0.7 MEuro Phare budget 0.7 MEuro Overall objectives(s) Strengthening of the administrative and institutional health care structures in Bulgaria in regard to the radiation protection, reduction of the radiation exposure of the population at medical use of ionizing radiation as required in the EC Basic Safety Standards 96/29 EUROTOM and the Medical Exposures Directive 97/43/EUROATOM, raising the level of the medical services and by this approaching a better quality of life. Objectively verifiable indicators • Achieved EC standards for radiation protection at medical use of ionizing radiation; • Applied Quality assurance structure in Radiotherapy, Nuclear Medicine and Diagnostic Radiology Sources of verification • Annual reports from MH and MoEW according to the harmonized legislation • Reports from the Steering Committee • NCRRP Project purposes Objectively Verifiable Indicators Sources of Verification Assumptions Increasing the safety use of ionizing radiation for medical purposes and effectiveness of early cancer diagnostics and treatment, applying comprehensive QA policy in diagnostic radiology, nuclear medicine and radiotherapy and innovation and enhancing the activity of the Secondary Standard Dosimetry Laboratory in accordance to the EC requirements. • Legislation documents implemented • QA and QC programmes implemented in special fields of Diagnostic Radiology and radiotherapy • National Diagnostic Reference Levels elaborated • SSDL activity enhanced • MoEW • MH, NCRRP • EU-Delegation • Results Objectively Verifiable Indicators Sources of Verification Assumptions R1 – Modernized and effectively operating National Secondary Standard Dosimetry Laboratory (SSDL) R2 – Developed system for quality audit in radiotherapy R3 – Optimised Patient Radiation Protection in Diagnostic Radiology and Nuclear Medicine by means of the Diagnostic Reference Levels (DRL) R4 – Technical Specifications elaborated • One methodology for calibration and metrological control of dosemeters used in Radiotherapy • One methodology for calibration and metrological control of dosemeters used in Radiation Protection • One methodology for calibration and metrological control of dosemeters and MoEW MH, NCRRP Regular progress reports Reports from working groups Reports from Steering Committee - Adequate expertise is provided -Support from other institutions concerned
  11. 11. quality control measuring devices used in Diagnostic Radiology • One methodology for inter-comparison between radiotherapy treatment systems • QA programme for radiotherapy, implemented in one reference radiotherapy centre • List of instructions for action at accidental exposures in radiotherapy • Updated DRL’s for eight radiography procedures and for most frequently performed NM-examinations • Established new DRL for three fluoroscopy guided procedures • National Survey of Computed Tomography (CT) practice (at least 30 scanners) and established DRL for ta least three CT-examinations • Enlarged national data base for patient dose monitoring including the number and frequency of X-ray examinations • Methodology for estimation of the population radiation exposure due to medical procedures (based on improved conversion coefficients) Activities Means Costs Assumptions 11
  12. 12. A1.1.Preparatory activities for SSDL modernization with long term training of three Bulgarian specialists in a partner SSDL for know-how transfer. A1.2. Definition and preparation of Technical Specifications A1.3. Supply of the necessary measurement and control equipment A1.4. Updating the methodology for calibration and metrological control of radiometers, dosimeters and quality control measuring devices used in Radiotherapy, Nuclear Medicine, Diagnostic Radiology and Radiation Protection on the base of the European and International standards. A1.5. Improvement of the methods for traceability of measurements and inter laboratory comparisons between radiotherapy treatment systems А1.6. Preparation and application for certification of SSDL in accordance with national institutional requirements. A2.1 Creation of a national protocol for Quality Control in radiotherapy A2.2. Development of QA programmes in radiotherapy A2.3. Set up of a national auditing group for QA in radiotherapy as to EC-standards A2.4. Pilot implementation of the QA and QC procedures in a leading radiotherapy centre A2.5. Drafting scenarios for most probable accidental exposures in radiotherapy and emergency action protocols. A3.1 Enlargement of the national survey as to the utilized methodology for measurement and evaluation of patient doses in conventional radiography A3.2. Review of the national survey on the applied activities and standards in NM A3.3. Setting a national survey of CT practice – defining methodology, performing measurements, dose assessment for the standard CT examinations A3.4. Updating the established DRL in Diagnostic Radiography and NM and determination of DRL in fluoroscopy procedures and CT. A3.5. Enlargement of the existing national data base for patient dose monitoring by elaboration of special sheet for collection of number and frequency of X-ray examinations. A3.6.Improving the methodology for estimation of the radiation burden of the population due to medical exposure. A3.7. Elaboration and review of the Technical Specifications for the equipment • Twinning contract Regular progress reports to Delegation Twinning reports Independent Monitoring Reports Minutes of meetings with Working Groups Inter ministerial and institutional co-operation 12
  13. 13. Annex 2 DETAILED IMPLEMENATION CHART Activities 2007 2008 J F M A M J J A S O N D J F M A M J A1.1.Preparatory activities for SSDL modernization with long term training of three Bulgarian specialists in a partner SSDL for know-how transfer. A1.4. Updating the methodology for calibration and metrological control of radiometers, dosimeters and quality control measuring devices used in Radiotherapy, Nuclear Medicine, Diagnostic Radiology and Radiation Protection on the base of the European and International standards. A1.5. Improvement of the methods for traceability of measurements and inter laboratory comparisons between radiotherapy treatment systems А1.6. Preparation and application for certification of SSDL in accordance with national institutional requirements. A2.1 Creation of a national protocol for Quality Control in radiotherapy A2.2. Development of QA programmes in radiotherapy A2.3. Set up of a national auditing group for QA in radiotherapy as to EC-standards A2.4. Pilot implementation of the QA and QC procedures in a leading radiotherapy centre A2.5. Drafting scenarios for most probable accidental exposures in radiotherapy and emergency action protocols A3.1 Enlargement of the national survey as to the utilized methodology for measurement and evaluation of patient doses in conventional radiography A3.2. Review of the national survey on the applied activities and standards in NM 13
  14. 14. A3.3. Setting a national survey of CT practice – defining methodology, performing measurements, dose assessment for the standard CT examinations A3.4. Updating the established DRL in Diagnostic Radiography and NM and determination of DRL in fluoroscopy guided procedures and CT. A3.5. Enlargement of the existing national data base for patient dose monitoring by elaboration of special sheet for collection of number and frequency of X-ray examinations A3.6.Improving the methodology for estimation of the radiation burden of the population due to medical exposure. A3.7. Elaboration and review of the Technical Specifications for the equipment Reports R1 R2 R3 R4 14
  15. 15. Annex 3. CONTRACTING AND DISBURSEMENT SCHEDULE Contracts 2006 2007 2008 O N D J F M A M J J A S O N D J F M A M J J A S O N D Contract 1 Twinning T T T T T T T T C I I I I I I I I I I I E T-Tendering, C- Contracting, I- Implementing, E- End 2007 2008 in €M 1q 2q 3q 4q 1q 2q 3q 4q Contract 1 Twinning Contracted 0.700 Disbursed 0.100 0.200 0.200 0.100 0.100 15
  16. 16. Annex 4. Financial appraisals for the investment project List of equipment for the National Center of Radiobiology and Radiation Protection, for the Oncological centers and for the Medical University Hospitals in Bulgaria Investment support No Item Unit price (Eur) Quantity Total (Eur) A. QC and RP equipment 1 Mammography imaging phantom for accrediatation and CT 1000 1 1000 2 CT imaging phantom for accreditation and QC 10000 1 10000 3 X-ray analyser options for CT 5000 5 25000 5 Additional accessories for X-ray measurement kits 4000 5 20000 4 Storage dewar and withdrawal device for liquid nitrogen 2000 1 2000 6 Isotope calibrators 8000 5 40000 7 Phantoms for NM 8000 5 40000 8 Calibration sources 2000 5 10000 9 National monitoring data base 60000 1 60000 10 Electronic personal dosemeters 500 20 10000 11 Direct individual dose control device for DR and NM 2000 20 40000 12 TL dosimetry system for personal dose monitoring and options 80000 1 80000 13 Whole body contamiination system 40000 1 40000 14 Beta/gamma contamination monitor 2000 10 20000 15 Portable area spectroscopic surveymeter 5000 7 35000 16 RP-control for neutrons 4000 3 12000 19 Area surveymeter for gama- and beta- radiation for RT 4000 11 44000 489000 B. QA in radiotherapy 16 Dosimetry systems incl.special ionizing chambers 20000 5 100000 17 Set of Ionisation chambers for radiotheraphy 15000 5 75000 18 Electric test device for dosimeters 2000 3 6000 19 Tissue characterization phantoms for CT 10000 4 40000 20 Multifunctional fantom for calibration and verification of TPS 5000 11 55000 21 Treatment planning systems 35000 9 315000 22 Positioning & immobilization systems 50000 11 550000 1141000 C. SSDL-equipment 23 Calibration benches incl. filters & control 200000 2 400000 24 X-ray generator 210000 1 210000 25 Radiation source calibration irradiator 60000 1 60000 26 Checking sources, incl. 242-Am,137-Cs,60-Co 5000 6 30000 27 Dosimetry system incl.spec.ionizing chambers 35000 2 70000 28 Mobile measur.&calibr.lab,incl.van 310000 1 310000 29 X-ray generator with Mo-target and energy range up to 50 kV 90000 1 90000 30 Interlock, radiation detection and warning systems 50000 2 100000 31 Calibration sources for beta-dosimetry 2500 10 25000 32 Radiometer for beta-dosimeter 15000 2 30000 1325000 16
  17. 17. Total 2955000 2955000 Annex 5 List of relevant laws and regulations 1. Act on Health, promulgated in State Gazette № 70 of August 10, 2004 2. Act of the Safe Use of Nuclear Energy, promulgated in the State Gazette No. 63 of June 28, 2002 3. Act on Measurements, promulgated in State Gazette № 46 of May 7, 2002 4. Ordinance No30 of the Ministry of Health from 31 October 2005 for conditions and order for providing protection of the individuals at Medical Exposure, promulgated in State Gazette № 91 of November 15, 2005 - according Directives 97/43 and 96/29 of EC 5. Regulation for Basic Norms for Radiation Protection, promulgated in the State Gazette No.73 of August 20, 2004 stated by the Governmental Decree No. 190 from 30 July 2004. 6. Ordinance No32 of the Ministry of Health from 7 November 2005 for performing of individual dose monitoring of individuals working with sources of ionizing radiation, promulgated in State Gazette № 91 of November 15, 2005 - according to Directive 96/29 of EC 7. Ordinance No29 of the Ministry of Health from 16 September 2005 for health norms and requirements at work with ionizing radiation – according Directive 96/29 of EC. 8. Ordinance for conditions and order for providing medical norms for protection of the individuals in case of nuclear accidents – according Directive 96/29 of EC. 9. Bulgaria Standard EN/ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories. May 2001. Annex 6 Reference list of relevant strategic plans and studies 1. National Strategy for the Development of Radiotherapy 2007-2011 2. National Strategy for Early Detection of Breast Cancer 2005-2010 3. National Strategy for Osteoporosis Treatment 17

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